VIIV Company Profile

What is the competitive landscape for VIIV, and when can generic versions of VIIV drugs launch?

VIIV has twenty-six approved drugs.

There are sixteen US patents protecting VIIV drugs.

There are five hundred and ninety-five patent family members on VIIV drugs in sixty-eight countries and two hundred and four supplementary protection certificates in eighteen countries.

Summary for VIIV

International Patents:	595
US Patents:	16
Tradenames:	19
Ingredients:	17
NDAs:	26
Patent Litigation for VIIV:	See patent lawsuits for VIIV
PTAB Cases with VIIV as patent owner:	See PTAB cases with VIIV as patent owner

Drugs and US Patents for VIIV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	TIVICAY PD	dolutegravir sodium	TABLET, FOR SUSPENSION;ORAL	213983-001	Jun 12, 2020		RX	Yes	Yes	9,242,986		Y	Y
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	10,927,129		Y	Y
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984-001	Nov 4, 2016		RX	Yes	Yes
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes	7,125,879		Y	Y

Expired US Patents for VIIV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	5,047,407*PED
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	6,180,639*PED
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	6,180,639
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	4,837,208
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998	5,034,394*PED

Paragraph IV (Patent) Challenges for VIIV drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	700 mg		2012-01-18
	Tablets	600 mg/300 mg		2007-09-27
	Tablets	600 mg/50 mg/300 mg		2017-08-14
	Tablets	150 mg and 300 mg		2007-10-16
	Tablets	150 mg and 300 mg		2011-08-08
	Oral Solution	20 mg/ml		2012-12-27
	Tablets	150 mg/300 mg		2007-06-26
	Tablets	10 mg, 25 mg and 50 mg		2017-08-14
	Tablets	300 mg/150 mg/300 mg		2011-03-22
	Oral Solution	10 mg/mL		2011-11-22
	Tablets	300 mg		2009-01-28

International Patents for VIIV Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	1284974
European Patent Office	2616076
Brazil	PI0617842
Czech Republic	20023806
World Intellectual Property Organization (WIPO)	2006024667

Supplementary Protection Certificates for VIIV Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	CR 2018 00036	Denmark		PRODUCT NAME: KOMBINATION AF DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. DOLUTEGRAVIRNATRIUM, OG RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. RILPIVIRINHYDROCHLORID; REG. NO/DATE: EU/1/18/1282/001-002 20180518
1663240	122016000108	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
2932970	122018000125	Germany		PRODUCT NAME: EINE KOMBINATION UMFASSEND DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z. B DOLUTEGRAVIR NATRIUM) UND RILPIVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B RILPIVIRIN HYDROCHLORID); REGISTRATION NO/DATE: EU/1/18/1282 20180516
1663240	93382	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
1284974	SPC/GB08/014	United Kingdom		PRODUCT NAME: MARAVIROC, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/07/418/001 20070918; UK EU/1/04/418/002 20070918; UK EU/1/04/418/003 20070918; UK EU/1/04/418/004 20070918; UK EU/1/04/418/005 20070918; UK EU/1/04/418/006 20070918; UK EU/1/04/418/007 20070918; UK EU/1/04/418/008 20070918; UK EU/1/04/418/009 20070918; UK EU/1/04/418/010 20070918

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Viiv Hlthcare